Senior Associate Quality Complaints

2 weeks ago

Hyderabad, Telangana, India Amgen Inc Full time ₹ 9,00,000 - ₹ 12,00,000 per year

The Senior Associate conducts low to medium complexity complaint investigations and determines if complaint investigations require issue for further investigation.

  • Evaluates and ensures triaged product complaint records align with applicable procedures
  • Evaluates and owns complaint records with basic investigations
  • Ensures quality of complaint records
  • Completes assigned assessments per applicable procedures
  • Applies analytical skills to evaluate sophisticated situations using multiple sources of information
  • Implements the complaint process per SOP requirements
  • Owns or manages the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide
  • Supports management of assigned projects or project tasks to achieve agreed results within time and with encouraged quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance

Basic Qualifications:

  • Masters degree and 1 to 3 years of Quality experience OR
  • Bachelors degree and 3 to 5 years of Quality experience OR
  • Diploma and 7 to 9 years of Quality experience

Preferred Qualifications:

  • Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry
  • Bachelors Degree in a Science Field
  • Ability to successfully manage workload to timelines
  • Familiarity with basic project management tools
  • Ability to operate in a matrixed or team environment with site, functional, and senior management leadership
  • Experience in driving decision making by using the DAI principles
  • Understanding of quality and industry requirements/expectations of a QMS
  • Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
  • Ability to negotiate a position after taking feedback from multiple sources
  • Demonstrated ability to lead functional teams, consistently deliver timely, and high-quality results
  • Ability to translate business and key collaborator feedback and requirements into accurate and efficient processes using clear language and format

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